Registry Data Points to Success Predictors for GERD Treatment

It helps to sell your device if you can add a splash of scientific credibility to your sales pitch. That’s probably why we’re seeing Endogastric Solutions helping physicians to choose their device by referencing a paper which spells out which patients it’ll work best on.

Background

Gastroesophageal Reflux Disease (GERD) has become something of a hot potato in recent months as companies have recognised that device-driven options may do a better job than Bisodol or even the more sophisticated proton pump inhibitors (PPIs). What makes it even more attractive is the sheer number of potential candidates, GERD being one of the more commonly presenting conditions at the doctor’s surgery.

GERD is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up into the esophagus, causing heartburn and possible injury to the esophageal lining.

The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum dose usage of prescription medications has been linked to a variety of other health complications however, so device makers have been searching for quick fix solutions, many of which we’ve featured on our pages.

One such comes from EngoGastric Solutions®, a self proclaimed leader in endoluminal reconstructive treatment for the condition. Its Transoral Incisionless Fundoplication (TIF®) procedure is performed, as the title suggests, entirely through the mouth without the need for external incisions through the skin. It offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. Indeed studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.

The news then is that a new publication of US registry data has come up with some proposed patient factors, predictive of positive outcomes following tran,soral incisionless fundoplication (TIF). According to a press release issued by EndoGastric Solutions, the study demonstrates that patients with an objective diagnosis of GERD who experience persistent typical symptoms while taking proton pump inhibitor (PPI) medication are likely to respond favorably to the TIF procedure.

In this study, presence of esophagitis objectively confirmed a diagnosis of GERD. Persistent typical symptoms of GERD were measured by several validated surveys; however, a GERD-HRQL score of greater than or equal to 15 while on PPIs was found to be a positive predictor for a successful outcome from a TIF procedure.

The analysis includes results from 158 consecutive patients who underwent the TIF procedure at 14 U.S. centers, including 13 general surgery practices and one gastroenterology practice. The study was designed to assess the impact of the TIF procedure on patients with chronic GERD. Follow-up is ongoing for the registry study patient population; the median follow-up for this analysis was 22 (range 10-43) months.This new data has been published online in the journal Surgical Endoscopy here. It’s quite data heavy, but an interesting piece, noting that it (and several authors including principle name Reginald Bell quoted below, are supported by research grants, honoraria or consulting agreements with EndoGastric Solutions. There we go, our disclosure duty done.

Physician comments

“GERD is a very common condition. Many patients do not respond adequately to medical therapy and seek minimally invasive treatment options,” said Reginald Bell, MD, general surgeon at SurgOne Foregut Institute in Englewood, CO and primary author on the paper. “This data helps physicians identify patients with troublesome reflux symptoms who are most likely to have a successful outcome following the TIF procedure.”

Company comments

“The data informs clinical practice by shedding light on proper patient selection and adds to the existing body of evidence on TIF,” said Skip Baldino, EGS President and CEO. “The data should provide additional insights on proper patient selection and could be used to define specific patients that are most likely to benefit from our technology.”